A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis.

IF 3.5 3区 医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-10-01 Epub Date: 2024-10-02 DOI:10.1007/s13555-024-01268-z
Andrew F Alexis, Melinda Gooderham, Shawn G Kwatra, Ahmad Amin, Susan Taylor, Ramon Espaillat, Trisha Rettig, Tianshuang Wu, Linyu Shi, Mark I Kaldas, Deanne M Dilley, Ranjeeta Sinvhal, Chudy Nduaka, Benjamin Lockshin
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Abstract

Introduction: Historically, patients with skin of color are underdiagnosed with psoriasis and underrepresented in clinical trials. In this study, we assess the efficacy and safety of risankizumab in patients with moderate-to-severe plaque psoriasis by race and ethnicity in the open label extension LIMMitless (NCT03047395).

Methods: Patients received continuous treatment with 150 mg risankizumab through their initial trial and the open label extension. Patients self-identified their race and ethnicity. Efficacy was assessed using Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety is reported by events/100 patient-years.

Results: A total of 897 patients (race: 662 White, 196 Asian, 25 Black or African American, 14 Other; ethnicity: 98 Hispanic or Latino, 799 non-Hispanic or Latino) were included in this analysis. Compared to baseline, patients had a mean percent reduction in PASI between 94.6% (Asian) and 99.3% (Black or African American) and reported mean percent improvements in DLQI ranging from 87.1% (Asian and Black or African American) to 93.7% (Hispanic or Latino) at week 100.

Conclusion: While the data presented here comprise a small retrospective descriptive analysis and cannot detect statistical differences, efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis appears similar across the racial and ethnic groups studied and no new safety signals were detected.

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中度至重度银屑病患者中不同种族和人种利赞单抗疗效和安全性的描述性事后分析。
简介:一直以来,有色人种银屑病患者的诊断率较低,在临床试验中的代表性也不足。在这项研究中,我们将在开放标签扩展项目 LIMMitless(NCT03047395)中,按种族和民族评估利妥珠单抗对中重度斑块状银屑病患者的疗效和安全性:患者在初始试验和开放标签扩展试验中持续接受 150 毫克利抗珠单抗治疗。患者自报种族和民族。疗效采用银屑病面积严重程度指数(PASI)和皮肤病生活质量指数(DLQI)进行评估。安全性按每 100 患者年发生的事件进行报告:本分析共纳入 897 名患者(种族:662 名白人、196 名亚裔、25 名黑人或非裔美国人、14 名其他;族裔:98 名西班牙裔或拉丁裔、799 名非西班牙裔或拉丁裔)。与基线相比,患者的 PASI 平均下降率介于 94.6%(亚裔)和 99.3%(黑人或非裔美国人)之间,第 100 周的 DLQI 平均改善率介于 87.1%(亚裔和黑人或非裔美国人)和 93.7%(西班牙裔或拉丁裔美国人)之间:虽然本文提供的数据只是一个小型的回顾性描述分析,无法检测出统计学差异,但利桑珠单抗治疗中重度斑块状银屑病的疗效在所研究的种族和民族群体中似乎相似,而且没有发现新的安全信号。
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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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